EUCTR2010-022510-11-DE进行中（未招募）不适用
A multicenter, open-label, dose ranging study to determine the pharmacokinetics and pharmacodynamics of mepolizumab administered intravenously or subcutaneously to adult asthmatic subjects with elevated blood eosinophil levels
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 65
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Males or eligible females between 18 and 65 years of age inclusive, at the time of
- •signing the informed consent; Non-childbearing potential is defined as pre menopausal females with a documented tubal ligation or hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea [in questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) > 40 MlU/ml and estradiol < 40 pg/ml (<147pmol/L) is confirmatory]. To be eligible for entry into the study, females of childbearing potential and females whose menopausal status is in question must commit to consistent and correct use of an acceptable method of birth control as defined in Section 7.1.1 of the protocol from one month prior to the first dose of investigational product until 4 months after the last dose of investigational product.
- •2. History of asthma for at least one year.
- •3. Subjects must be on a stable dose of an inhaled corticosteroid or combination (ICS+LABA) therapy for at least 12 weeks prior to screening.
- •4. FEV1=45% and <90 % of predicted normal value during screening (obtained between 6:00 AM and 1:00 PM).
- •5. Evidence of airway reversibility (FEV1=12%) within 30 minutes of inhalation of albuterol OR airway hyperresponsiveness (PC20 of <8mg/mL or PD20 of <7.8 µ mol methacholine/histamine) documented in the 12 months prior to randomization.
- •6. Subjects with documented evidence of elevated blood eosinophilia levels (>0.2 cells 10^9/L) within 12 months of screening and evidence of elevated blood eosinophilia levels (>0.2 cells 10^9/L) at screening.
- •7. Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 58
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. QTcF =450 msec; or QTcF = 480 msec in subjects with Bundle Branch Block.
- •2. AST, ALT, alkaline phosphatase and bilirubin = 1.5xULN (isolated bilirubin
- •<1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin =35%).
- •3. Subjects with elevated blood eosinophil levels which is not related to asthma
- •4. Current smokers (any subject who has smoked within the six months prior to
- •screening or has a positive urine cotinine at screening) or subjects with a smoking
- •history of >10 pack years calculated as follows:view protocol for further information.
- •5. Presence of a clinically important lung condition other than asthma including current infection, bronchiectasis, pulmonary fibrosis, bronchopulmonary aspergillosis,
- •Churg-Strauss syndrome, or diagnoses of emphysema or chronic bronchitis (chronic
- •obstructive pulmonary disease other than asthma) or a history of lung cancer.
- •6. An asthma exacerbation or respiratory tract infection within six weeks prior to
- •screening (an exacerbation is defined as worsening asthma requiring the use of
- •systemic corticosteroids and/or emergency department visit, hospitalisation).
- •7. Subjects with a parasitic infestation within six months of screening.
- •8. A current malignancy or previous history of cancer in remission for less than five
- •years prior screening (except for localized carcinoma of the skin that has been
- •resected for cure).
- •9. Subjects who have clinically significant cardiovascular, endocrine, autoimmune,
- •metabolic, neurological, renal, gastrointestinal, hepatic, haematological or any other
- •system abnormalities that are uncontrolled with standard treatment.
- •10. Unstable liver disease (as defined by the presence of ascites, encephalopathy,
- •coagulopathy, hypoalbuminaemia, esophageal or gastric varices or persistent
- •jaundice), cirrhosis, and known biliary abnormalities (with the exception of Gilbert’s
- •syndrome or asymptomatic gallstones).
- •11. Subjects with a known immunodeficiency (e.g. human immunodeficiency virus –
- •12. A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody
- •result within three months of screening.
- •13. Subjects who have received omalizumab [Xolair] within 130 days of administration of the first dose of study medication.
- •14. Subjects with recent history (within two years prior to screening) of alcohol misuse or substance abuse prior screening.
- •15. A positive pre-study drug/alcohol test at screening.
研究者
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